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The major metals of potential health concern found in food, drugs (medicines), and dietary supplements are lead, cadmium, mercury, and arsenic. Other metals, such as chromium, copper, manganese, molybdenum, vanadium, nickel, osmium, rhodium, ruthenium, iridium, palladium, and platinum, may be used or introduced during manufacturing and may be controlled in the final article as impurities. Screening for metals in medicines and dietary supplements rarely indicates the presence of toxic metal impurities at levels of concern. The setting of heavy metal limits is appropriate for medicines and is appropriate for supplements when heavy metals are likely or certain to contaminate a given product. Setting reasonable health-based limits for some of these metals is challenging because of their ubiquity in the environment, limitations of current analytical procedures, and other factors. Taken together, compendial tests for metals in food and drugs present an array of issues that challenge compendial scientists.

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This article reports on the measured quantity of acrolein from 15 commercial sheet-wrapped cigars using a validated standard smoking test method that derivatizes acrolein in the mainstream smoke with DNPH solution, and uses Liquid Chromatography/Ultra-Violet Detection (LC/UV) for separation and detection. These acrolein yields were similar to the levels found in the smoke from 35 commercial cigarette products measured in the same manner. Although sheet-wrapped cigar data were slightly more variable than those found for the cigarette data, this article reports that the production of acrolein is similar to cigarettes. The results demonstrate that sheet-wrapped cigars can be tested for acrolein yields in mainstream smoke using the same methods used for the evaluation of cigarettes.

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Biorelevant in vitro performance testing of orally administered dosage forms has become an important tool for the assessment of drug product in vivo behavior. An in vitro performance test which mimics the intraluminal performance of an oral dosage form is termed biorelevant. Biorelevant tests have been utilized to decrease the number of in vivo studies required during the drug development process and to mitigate the risk related to in vivo bioequivalence studies. This report reviews the ability of current in vitro performance tests to predict in vivo performance and generate successful in vitro and in vivo correlations for oral dosage forms. It also summarizes efforts to improve the predictability of biorelevant tests. The report is based on the presentations at the 2013 workshop, Biorelevant In Vitro Performance Testing of Orally Administered Dosage Forms, in Washington, DC, sponsored by the FIP Dissolution/Drug Release Focus Group in partnership with the American Association of Pharmaceutical Scientists (AAPS) and a symposium at the AAPS 2012 Annual meeting on the same topic.

k Kalman fllter based method for the correction of spectral response shifts In overlapped fluorescence spectra of polycyclic aromatic hydrocarbons (PAHs) has been developed. An Heratlve approach Is shown to correct spectral response shMs of PAHs In methanol, acetonltrlle, and tetrahydrofuran hydro-organlc solvent mlxtures. It Is also shown that correctlon for shifts In overlapped spectral responses consistlng of up to three components I s feasible. The correctlon of SMns of up to 10 nm In severely overlapped spectra is shown to be posslble, as well. The use of this method Is shown to slgnlflcantly Improve the quallty of the fit and yields more accurate concentratlon estknates of the lndlvldual contrlbutlons of overlapped fluorescence responses as compared to a regular Katman 111.

USP Dissolution <711> specifies performance verification testing (PVT) of dissolution Apparatus 1 and 2. Acceptance criteria are determined from a collaborative study and apply per tablet; i.e., each of the six tablets tested must fall within the specified acceptance criteria in order to pass. In this Stimuli article, USP proposes changing the form of the acceptance criteria to one that is consistent with the International Organization for Standardization's (ISO's) recommendations for proficiency testing. The new criteria would apply to the laboratory's average and standard deviation of the tablets tested. The article explains the rationale and shows the criteria that would be applied to USP Lot P Prednisone Reference Standard (RS) Tablets and USP Lot Q Salicylic Acid RS Tablets.